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OFFICE OF THE SE-CRETARY OF DEFENSE
V@l 1171'1@
20301
WASHINGTON, D.C
FEB 1 7 1994
MEMORANDUM TO DIRECTORS OF THE: DEFENSE AGENCIES
SUBJECT: Protection of Human Subjects in Research
on August 11, 1991, the Federal Common Policy for the
Protection of Human Subjects in Research was adopted by the
Department of Defense (DoD) and published in Title 32, Code of
Federal Regulations, Part 219-. Subsequently, Policy Guidance for
implementation of the Human Subjects Regulations was issued
jointly on June 10, 1993 by the Assistant Secretary of Defense
(Health Affairs) and the office of the Director, Defense Research
and Engineering to the Assistant Secretaries of the Military
Departments having cognizance for research, development, testing,
and acquisition.
It has been brought to our attention that at least one Defense
Agency has recently initiated a-program in medical technology.
To ensure that all Department of Defense Agencies are in
compliance with current human use regulations, it is requested
that each Director indicate viftether his Agency conducts or
provides funding support for intramural or extramural research
which involves human subject participation. If an Agency does
conduct or support human subjects research the required
administrative package will be provided to ensure Agency
compliance with the above Federal Regulation. For clarity,
research is defined as a systematic investigation, including
research, development, testing and evaluation, designed to
develop or contribute to generalizable knowledge. Activities
which meet this definition constitute research for purposes of
this policy, whether or not they are conducted or supported under
a program which is considered, research for other purposes. For
example, some demonstration and service programs may include
research activities. Human subjects is defined as a living
individual about whom an invEstigator (professional or student)
conducting research obtains data through intervention or
interaction with the individual, or obtains identifiable private
information regarding the individual used for research purposes.
Directors are requested to provide the status of Agency
participation in the conduct or support of intramural or
extramural human subject research by March 4, 1994 to
Director, Environmental and Life Sciences
office of the Director, Defense Research and Engineering
Pentagon Room 3D129
Washington, D.C., 20301-3030
Negative responses are required.
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my point of contact for this action is Captain John F.
Jemionek, MSC, USN, who may be contacted at (703) 697-1494. Your
assistance in ensuring total DoD compliance with Federal
Regulation in the area of human subject protection in research is
appreciated.
Edward D. Martin, M.D.
Acting Assistant Secretary
of Defense (Health Affairs)
J e V. Osterman
Director, Environmental
and Life Sciences
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Protection of Human
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REMARKS
1. (C/NF) PURPOSE: To provide the status of DIA's participation in the conduct or support of intramural or extramural
human subject research.
2. (U) BACKGROUND: The memorandum opposite provides the DIA response to requirements set forth in ESO tasker
#710.
3. (U) DISCUSSION:
a. (S/NF) DIA has determined that only one program (Project STAR GATE) falls within the definition of human
subject research. This research is conducted in two areas: in-house activities conducted by DIA civilian personnel and
external research activities conducted under DIA contract with the Science Applications International Corporation (SAIC).
b. (S/NF) Both the DIA and DoD General Counsels have determined that the STAR GATE Project constitutes
experimentation on human subjects. As required by Procedure 13 of DoD Directive 5240.1-R, approval for project
activities has been granted by the Deputy Secretary of Defense. DIA personnel involved with in-house investigations are
required to sign a Statement of Consent form approved by the DIA General Counsel. External research conducted by
SAIC is in full compliance with all applicable laws, Federal regulations and DoD instructions.
c. (S/NF) This matter was coordinated throughout all of DIA, and no other programs were determined to fall within
the definition of human subject research.
4. (U) RECOMMENDATION: Request the Director sign the memorandum opposite.
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1 Enclosure IreCtor
OSD Memorandum,, @iatlonal Military Intelligence
dtd 17 Feb 94, sab (U) Production Center
CLASSIFIED BY MULTIPLE SOURCES
DECLASSIFY ON OADR
NOT RELEASA13LE TO FOREIGN NATIONALS
DIA FORM I OCTOBER 1962 (Previous edition will be used until exhausted) DIAR 1
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